Patentability of human genes: the conceptual differences between the industrialised and Latin American countries
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ORIGINAL ARTICLE
Patentability of human genes: the conceptual differences between the industrialised and Latin American countries Salvador Darío Bergel 1
Received: 4 December 2014 / Accepted: 21 April 2015 # Springer-Verlag Berlin Heidelberg 2015
Abstract The patenting of human genes has generated considerable controversy, both in the doctrinal field and in the legal and administrative. In the core countries, particularly the USA and the European Union, a favourable criterion to patentability has been increasing, contrasting with the criteria adopted by Latin American countries, which almost unanimously banned the patentability of genes and gene sequences. This issue not only has legal connotations, but also ethical issues come into play. Particularly in the USA, the recent decision of the Supreme Court in the Myriad case is part of a pro-patent movement, even when its superficial reading seems to be oriented in the opposite direction. In the European Union, the criterion that favours human intervention, whatever its gravitation in the results, tips the balance in favour of patentability.
Introduction The purpose of this study is to crystallise the differences between legal regulations and case law in the USA and the European Union, on the one hand, and the Latin American countries, on the other, with regard to the patentability of genes and sequences of human genes. These differences are based on the existence of conflicting legal and ethical criteria. This article is part of the special issue on BGenetics and Ethics in Latin America^. * Salvador Darío Bergel [email protected] 1
UNESCO Chair in Bioethics, University of Buenos Aires, Florida 537, 18th Floor, C1005AAK Buenos Aires, Argentina
Currently, patent law is set to the economic policy of the states. It is difficult, if not impossible, to reconcile points of view that enable to make their contents universal.
The subject under discussion When the Human Genome Project set out to sequence the whole human genome, it rapidly became apparent that the information obtained could have a significant market value. To make this information freely available to anyone who wanted to use it would mean giving up an important Bbusiness opportunity^. The possibility of commercialising the human genome was rejected by scientists at the meeting held in Bermuda in February 1996, during which they assumed two commitments (Marshall 2001): (1) to share the results of sequencing Bas soon as possible^, whenever the stretch of DNA sequenced exceeded a thousand base pairs, and (2) to send this information within 24 h to the public database GenBank. The battle for the patenting of human genetic material began in July 1991, the date on which the National Institute of Health (NIH) filed a claim in the US Patent Office (US Patent and Trademark Office-USPTO) to patent the partial sequences of 337 genes. This caused a significant reaction in the scientific world (Leslie 1991). In February 1992, new patents for 2375 expressed sequence tags (ESTs) were claimed but the USPTO rejected the
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